Job Description
Join to apply for the Regulatory Affairs Manager role at Katalyst CRO
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Join to apply for the Regulatory Affairs Manager role at Katalyst CRO
- In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more.
- You will work cross-functionally with Clinical, Global Regulatory Affairs. counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
- Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management.
- Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies.
- Oversee and coach a team of regulatory professionals to support both strategic and operational objectives.
- Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.).
- Define and execute submission strategies to meet timelines and business goals.
- Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review.
- Monitor changes in international regulatory environments and communicate impacts to internal teams.
- Represent the company in industry groups or regulatory associations, where appropriate.
- Support training and knowledge-sharing on country-specific regulatory requirements within the organization.
Responsibilities - In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more.
- You will work cross-functionally with Clinical, Global Regulatory Affairs. counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
- Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management.
- Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies.
- Oversee and coach a team of regulatory professionals to support both strategic and operational objectives.
- Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.).
- Define and execute submission strategies to meet timelines and business goals.
- Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review.
- Monitor changes in international regulatory environments and communicate impacts to internal teams.
- Represent the company in industry groups or regulatory associations, where appropriate.
- Support training and knowledge-sharing on country-specific regulatory requirements within the organization.
Requirements - BS/MS degree or equivalent experience required.
- Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR.
- Superior presentation skills when communicating with all levels of the organization, business partners, and external sources.
- Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment.
- Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.
Seniority level
Seniority level
Associate
Employment type
Job function
Job function
Legal -
Industries
Pharmaceutical Manufacturing
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